Recruiting

RTMS

Sponsor:

Stanford University

Code:

NCT04870255

Conditions

Depressive Disorder, Major

Borderline Personality Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Left Dorsolateral Prefrontal Cortex (L-DLPFC)

Dorsomedial Prefrontal Cortex (DMPFC)

Sham Stimulation

Study Details

Brief summary:

This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).

Conditions

Depressive Disorder, Major

Borderline Personality Disorder

Study ID

NCT04870255

Start date

Jul 20, 2021

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or Female, between the ages of 18 and 80 at the time of screening.
  • Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
  • Diagnosed with Major Depressive Disorder (MDD) or Bipolar II, or unspecified depressive disorder AND Borderline Personality Disorder or trait, with a current Mood Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
  • MADRS score of ≥20 at screening (Visit 1).
  • TMS naive.
  • Access to ongoing psychiatric care before and after completion of the study.
  • Access to clinical rTMS after study completion.
  • In good general health, as evidenced by medical history.
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
  • Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.

Exclusion Criteria:

  • Pregnancy
  • The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia
  • Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
  • Current mania or psychosis
  • Bipolar I Disorder and primary psychotic disorders.
  • Autism Spectrum disorder or Intellectual Disability
  • A diagnosis of obsessive-compulsive disorder (OCD)
  • Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
  • Urine screening test positive for illicit substances.
  • Any history of ECT (greater than 8 sessions) without meeting responder criteria
  • Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
  • History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
  • Untreated or insufficiently treated endocrine disorder.
  • Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
  • Contraindications to MRI (ferromagnetic metal in their body).
  • Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
  • Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)
  • Treatment with another investigational drug or other intervention within the study period.
  • Any other condition deemed by the PI to interfere with the study or increase risk to the participant.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Left Dorsolateral Prefrontal Cortex (L-DLPFC)

The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)

active comparator: Dorsomedial Prefrontal Cortex (DMPFC)

The accelerated theta burst stimulation protocol will be applied to the dorsomedial prefrontal cortex (DMPFC)

sham comparator: Sham stimulation

Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

Interventions

Left Dorsolateral Prefrontal Cortex (L-DLPFC)

Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered using the Magventure Magpro X100 TMS system.

Dorsomedial Prefrontal Cortex (DMPFC)

Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the DMPFC. Stimulation intensity will be standardized at 100% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered using the Magventure Magpro X100 TMS system.

Sham Stimulation

Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC.

Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.

Primary outcome measure

  • Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS. [ Time Frame: At baseline (pre-intervention), during the intervention and immediately after the intervention. ]

Central Contacts and Locations

Central contacts

Bora Kim, MD, MAS

650-800-6929borakim2@stanford.edu

Nick Bassano, MSW

650-800-6929nbassano@stanford.edu

Locations

Stanford Hospital

Recruiting

Stanford, California, United States, 94305

Contacts

Nick Bassano, MSW1

6504347844nbassano@stanford.edu

Katina Marchione

kfmarch@stanford.edu

Principal Investigator:

David Spiegel, MD

More Information

Sponsor

Stanford University

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Depression
  • Neuromodulation
  • Transcranial Magnetic Stimulation
  • Borderline Personality Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-11.